Phase III Study of PET-Directed Local or Systemic Therapy Intensification in Prostate Cancer Patients with Post-Prostatectomy Biochemical Recurrence
Objective
Primary Objectives For patients without PET-evidence of extrapelvic metastases, to evaluate whether the addition of enhanced systemic therapy to SOC salvage RT could prolong PFS. For patients with PET-evidence of extrapelvic metastases, to evaluate whether the addition of metastasis-directed RT to enhanced systemic therapy and SOC salvage RT could prolong PFS.
Secondary Objectives To evaluate overall survival (OS) in each arm. To evaluate event-free survival (EFS) in each arm. To evaluate time to PSA progression using Prostate Cancer Working Group (PCWG) 3 criteria in each arm. To assess the incidence of adverse events with the addition of enhanced systemic therapy in patients without PET-evidence of extrapelvic metastases. To assess the incidence of adverse events with local ablative metastasis-directed RT for PET-positive metastatic disease in patients with PET-evidence of extrapelvic metastases. To estimate the detection rate of PET/CT at the patient and regional level, and to evaluate its concordance with the follow-up FDA-approved conventional imaging modalities (CIM) considered standard-of-care per institution, including CT, bone scintigraphy, MRI and PET imaging performed as PET/CT and/or PET/MR using 11C-Choline and/or 18F-Sodium Fluoride. To determine the distribution of PET-positive lesions among anatomic sites (prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases) in patients with post-RP BCR, correlated with PSA (level, doubling time, velocity) and other relevant clinical parameters. To determine the value of repeat PET at time of second PSA recurrence, or 12 months after completion of enhanced systemic therapy, whichever comes first (PET2) to assess response to therapy (enhanced systemic therapy +/- focal RT and/or ADT) compared to standard response assessments (PSA and CIM).
